TY - JOUR
T1 - Efficacy and safety of combination therapy with delavirdine and zidovudine
T2 - A European/Australian phase II trial
AU - Been-Tiktak, Anne M.M.
AU - Boucher, Charles A.B.
AU - Brun-Vezinet, Françoise
AU - Joly, Véronique
AU - Mulder, Jan W.
AU - Jost, J.
AU - Cooper, David A.
AU - Moroni, Mauro
AU - Gatell, José M.
AU - Staszewski, Schlomo
AU - Colebunders, Robert
AU - Stewart, Graeme J.
AU - Hawkins, David A.
AU - Johnson, Margaret A.
AU - Parkin, Jacqueline M.
AU - Kennedy, Dermot H.
AU - Hoy, Jennifer F.
AU - Borleffs, Jan C.C.
PY - 1999/1/1
Y1 - 1999/1/1
N2 - The objective of the study was to investigate the safety and antiviral effect of three delavirdine dose regimens or placebo in combination with zidovudine in patients who were already taking zidovudine. Eighty-nine symptomatic HIV-1 seropositive individuals with CD4+ cell counts between 50 and 350 cells/μl were included in this trial The influence of combination therapy on viral susceptibility to both zidovudine and delavirdine was investigated. Death or the occurrence, or re-occurrence of an AIDS-defining illness was considered as a clinical endpoint. The addition of delavirdine to the antiretroviral treatment regimen resulted in a significant, but transient, reduction in virus load, as determined by quantitative RNA measurements. CD4+ cell count did not change significantly. Susceptibility to zidovudine remained unchanged after 12 weeks of combination therapy, while 70% of the patients demonstrated a substantial decrease (>10-fold) in sensitivity to delavirdine. Two patients suffered from an AIDS-defining disease during the study. No deaths occurred. Generally, the drug appeared to be safe. Skin rash was the most frequently observed adverse event (52%). In most patients the rash either resolved spontaneously or was treated successfully with a short course of antihistamines. The definite place of the compound in the management of HIV disease, in particular when given in combination with other antiretroviral agents, remains to be further explored. Copyright (C) 1999 Elsevier Science B.V. and International Society of Chemotherapy.
AB - The objective of the study was to investigate the safety and antiviral effect of three delavirdine dose regimens or placebo in combination with zidovudine in patients who were already taking zidovudine. Eighty-nine symptomatic HIV-1 seropositive individuals with CD4+ cell counts between 50 and 350 cells/μl were included in this trial The influence of combination therapy on viral susceptibility to both zidovudine and delavirdine was investigated. Death or the occurrence, or re-occurrence of an AIDS-defining illness was considered as a clinical endpoint. The addition of delavirdine to the antiretroviral treatment regimen resulted in a significant, but transient, reduction in virus load, as determined by quantitative RNA measurements. CD4+ cell count did not change significantly. Susceptibility to zidovudine remained unchanged after 12 weeks of combination therapy, while 70% of the patients demonstrated a substantial decrease (>10-fold) in sensitivity to delavirdine. Two patients suffered from an AIDS-defining disease during the study. No deaths occurred. Generally, the drug appeared to be safe. Skin rash was the most frequently observed adverse event (52%). In most patients the rash either resolved spontaneously or was treated successfully with a short course of antihistamines. The definite place of the compound in the management of HIV disease, in particular when given in combination with other antiretroviral agents, remains to be further explored. Copyright (C) 1999 Elsevier Science B.V. and International Society of Chemotherapy.
KW - Delavirdine
KW - HIV
KW - Zidovudine
UR - http://www.scopus.com/inward/record.url?scp=18244412616&partnerID=8YFLogxK
U2 - 10.1016/S0924-8579(98)00082-X
DO - 10.1016/S0924-8579(98)00082-X
M3 - Article
C2 - 10075273
AN - SCOPUS:18244412616
SN - 0924-8579
VL - 11
JO - International Journal of Antimicrobial Agents
JF - International Journal of Antimicrobial Agents
IS - 1
ER -
